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Sponsored by: |
Cell Therapeutics |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00551239 |
RATIONALE: Drugs used in chemotherapy, such as fludarabine and pixantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether giving fludarabine together with rituximab is more effective with or without pixantrone in treating indolent non-Hodgkin lymphoma.
PURPOSE: This randomized phase III trial is studying fludarabine and rituximab to compare how well they work with or without pixantrone in treating patients with relapsed or refractory indolent non-Hodgkin lymphoma.
Condition | Intervention | Phase |
Leukemia Lymphoma |
Drug: fludarabine phosphate Drug: pixantrone Drug: rituximab |
Phase III |
MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma |
ChemIDplus related topics: | Fludarabine Fludarabine monophosphate Rituximab 6,9-Bis((2-aminoethyl)amino)benzo(g)isoquinoline-5,10-dione |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Phase III Trial Comparing the Combination of Fludarabine, BBR 2778 (Pixantrone) and Rituximab (FP-R) With the Combination of Fludarabine and Rituximab (F-R) in the Treatment of Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 300 |
Study Start Date: | August 2007 |
Arms | Assigned Interventions |
Arm I (control): Active Comparator
Patients receive rituximab IV on day 1 and fludarabine phosphate IV on days 2-4. Treatment repeats every 28 days for up to 6 courses.
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Drug: fludarabine phosphate
Given IV
Drug: rituximab
Given IV
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Arm II: Experimental
Patients receive rituximab and fludarabine phosphate as in arm I. Patients also receive pixantrone IV on day 2. Treatment repeats every 28 days for up to 6 courses.
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Drug: fludarabine phosphate
Given IV
Drug: pixantrone
Given IV
Drug: rituximab
Given IV
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified by Follicular Lymphoma International Prognostic Index (FLIPI) score (0 or 1 vs ≥ 2), number of prior treatments (1 or 2 vs > 2), and prior anti-CD20 regimen (yes vs no). Patients are randomized to 1 of 2 treatment arms.
NOTE: *Only patients achieving complete response, unconfirmed complete response, or partial response after 4 courses receive courses 5 and 6.
After completion of study therapy, patients are followed periodically for up to 5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed relapsed or refractory indolent non-Hodgkin lymphoma (NHL)
Histological assessment must be confirmed by an independent laboratory prior to study randomization
Any stage disease (with or without B symptoms), including the following:
Grade I or II follicular lymphoma, defined as follows:
Small lymphocytic lymphoma or chronic lymphocytic leukemia (CLL)
Measurable disease
Patients must have received at least 1 prior therapy
No active CNS involvement based on clinical evaluation
PATIENT CHARACTERISTICS:
No clinical symptoms suggesting unresolved HIV, hepatitis B, or hepatitis C virus infection
PRIOR CONCURRENT THERAPY:
No concurrent radiotherapy to target lesions
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000573364, CTI-CRRI 0807003 |
First Received: | October 22, 2007 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00551239 |
Health Authority: | United States: Food and Drug Administration |
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